Repetitive Transcranial Magnetic Stimulation for the Treatment of Freezing of Gait in Parkinson's Disease

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Unknown

Conditions: Gait Disorders, Neurologic; Parkinson Disease

Treatments: Device: sham stimulation; Device: rTMS

Study type: Interventional

Funder types: Other

Identifiers

NCT04431570

rTMSPDFOG-PUMCH

Details and patient eligibility

About

Freezing of gait (FOG) is a common and devastating symptom in advanced stage Parkinson's disease (PD), which contributes to falls and disability. Unfortunately, there is no effective pharmacological treatment for FOG. It is suggested that the cortex-basal ganglia circuit, especially the frontal lobe, plays an important role in the pathogenesis of FOG. Repetitive transcranial magnetic stimulation (rTMS) effects over the cortex and affects the subcortical neural circuits. Previous studies have demonstrated that rTMS can improve FOG for PD patients. In the present randomized controlled trial (RCT) study, the invastigators aim to investigate the efficiency of rTMS over different motor regions of frontal lobe. The efficacy of treatment is evaluated by the score of FOG questionnaire and FOG provoking test, and the changing of neural network shown by functional magnetic resonance imaging (FMRI). Then the effects of rTMS over different brain regions will be compared for choosing a better target. The study will provide the evidence for non-invasive neuro-modulation of Parkinson's disease with freezing of gait (PD-FOG).

Enrollment: 66 estimated patients

Sex: All

Ages: 50 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects fulfilled the diagnosis of idiopathic Parkinson's disease according to MDS-PD criteria
• Hoehn & Yahr (H-Y) stage was 2 or 3
• All subjects had freezing of gait which was identified by FOGQ

Exclusion criteria

• cognitive impairment (MMSE score<22) or major depression (HAMD-24 score>25)
• severe visual and/or haring impairment
• significant medical or psychiatric illnesses
• history of deep brain stimulation (DBS) surgery or pacemaker implantation. MRI cannot be performed in those patients
• current treatment with medication cannot be maintained during the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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66 participants in 3 patient groups

rTMS over M1 region

Experimental group

Description:

The stimulus intensity was set to 100% of the resting motor threshold. Ten sessions of rTMS were delivered over 2 weeks, one session per day for 5 consecutive days per week. Each session consisted of 10 trains of 100 pulses at 10Hz with an inter-train interval of 40 seconds. In this group, the target of rTMS is M1 region.

Treatment:

Device: rTMS

rTMS over supplementary motor area (SMA)

Experimental group

Description:

The stimulus intensity was set to 100% of the resting motor threshold. Ten sessions of rTMS were delivered over 2 weeks, one session per day for 5 consecutive days per week. Each session consisted of 10 trains of 100 pulses at 10Hz with an inter-train interval of 40 seconds. In this group, the target of rTMS is SMA region.

Treatment:

Device: rTMS

sham stimulation

Sham Comparator group

Treatment:

Device: sham stimulation